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Full notification Final report - General information Notification Number B/DE/22/PEI4638 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 27/08/2021 Title of the Project A Phase 1/2, First-in-Human, Open-Label, Accelerated Titration, Two-part Clinical Trial of TK-8001 (MAGE-A1-directed TCR-Transduced Autologous CD8+ T cells) in Subjects with HLA-A*02:01 Genotype and Advanced-Stage/Metastatic, MAGE-A1+ Solid Tumors that Either have no Approved Therapeutic Alternative(s) Anymore or are in NonCurable State and have Received a Minimum of Two Lines of Systemic Therapy. Proposed period of release: 01/01/2022 to 31/12/2025 Name of the Institute(s) or Company(ies) T-knife GmbH, Robert-Rössle-Straße 10 13125 Berlin Germany
Is the same GMO been notified elsewhere by the same notifier? Yes:
Belgium; Germany;
Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): GMO characterization GMO is a: Other Identity of the GMO: Genus: Human Species: Homo Sapiens TK-8001: Autologous human CD8+ T cells transduced ex vivo with a replication-deficient gammaretroviral vector to express a T cell receptor (TCR) directed against the cancer-testis antigen MAGE-A1.  Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Human Genus: Homo Species: Homo Sapiens Subspecies: Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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